A prospective feasibility study of chemotherapy under covered HANAROSTENT placement in stage IV obstructive colon cancer

UMIN ID: UMIN000054377

Registered date:01/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Stage IV obstructive colon cancer
• Date of first enrollment: 2024/07/15
• Target sample size: 27
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: One-year SEMS-related adverse events
• Secondary Outcome: Progression-free survival of first-line chemotherapy, Overall response rate of first-line chemotherapy, Adverse events of first-line chemotherapy, Overall survival, Surgery-free survival, Overall SEMS-related adverse events, Duration of SEMS patency, Analysis of tumor markers

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: 1. clinical stage T4b 2. Multiple SEMS placement 3. The presence of multiple malignancies 4. BT => 38.0 (celsius) 5. Infections disease that requires systemic treatment 6. The presence of massive body fluids (pleural, ascites, pericardial fluid, etc.) 7. Administration of anticoagulant drugs or multiple antiplatet drugs 8. Impossible cases that conduct surgery under general anesthesia 9. Sever heart and lung dysfunction 10. Administration of steroid or immune suppressive drugs 11. Uncontrolled diabetes mellitus 12. Active bleeding 13. History of serious drug hypersensitivity 14. Women who are pregnant, possibly pregnant, within 28 days postpartum, or lactating, or who are unwilling to use contraception. Men who do not intend to use contraception. 15. Severe mental disorder 16. Impossible confirmation of own will (ex. dementia) 17. Inappropriateness with physician's judgement

Related Information

• Primary Sponsor: Nagoya City University
• Source(s) of Monetary Support: M.I. Tech Co., Ltd.